ES2371643T3 - IMPLANTABLE DEVICE. - Google Patents

Abstract

A supporting structure formed from a single wire-like element (10) is used in an implant (1) for use in human or animal bodies for closing holes etc. or for making connections, where the supporting structure has a primary form (first operating state) with a large length to diameter (L/D) ratio along one axis (63) and a secondary form with a small L/D ratio An implantable device (1) for use in human or animal bodies for closing holes, cavities, passages in organs etc. or for making definite connections between walls, organs, cavities etc., has a supporting structure (SS) with a proximal part (20) and a distal part (30), which shows a large length to diameter (L/D) ratio along one axis (63) in a first operating state (primary form) and a small L/D ratio in a second operating state (secondary form). The supporting structure (SS) is formed from a single wire-like element (10). Independent claims are also included for (1) A positioning system for (1), with a feed element (5), a guide wire (6, 9) and/or inner mandrel and retaining wire(s) (80, 81), in which wires (6) and (80, 81) are attached to the proximal end of (1), which can be converted from the primary form into the secondary form and vice versa by moving these wires relative to element (5) (2) a set comprising the above positioning system and one or more implantable devices (1) (3) a method for the production of (1) by winding the form for a base supporting structure from a wire element (10), annealing the form to stabilize it, converting the structure from the base form to the required secondary form and then annealing the secondary form to stabilize and imprint it.

Description

Implantable device

The invention relates to an implantable device for use in the human and / or animal body for the partial closure or closure of defective openings, cavities, organic pathways etc. or to make a defined joint opening between walls, organs, cavities etc., with a support structure that in a first state of operation (primary form) has a large relationship between the length and the transverse extension along an axis and that, in a second operating state (secondary form), it has a smaller relationship between the length and the transverse extension along the axis, the support structure having a proximal section and a distal section.

Implants are known in the state of the art. For example, US 5,846,261 discloses a folding medical device that has a flat metal textile formation with a bead on the proximal end and on the distal end of a prefabricated structure, fixing devices being provided at the ends. proximal and distal flat metal textile formation in the bead breaker. In its extended state, this medical device is shaped like a bell. The flat textile formation is formed by a multitude of interwoven wires gathered at their ends. Also according to US5,725,552 a flat metal textile formation is made, a fixing device being applied respectively at the proximal end and at the distal end. The different metal cords or threads of the multitude of metal cords or threads meet in said fixing device. In the extended state, in turn, it is a bell shape. According to documents US6,368,339B and US6,123,715 a procedure for developing such a medical device, which can be deployed in a channel or a cavity of a patient's body, is described. In a folded configuration, the device can be passed through a catheter to reach the point of the patient's body where it is to be deployed. In this procedure, first, a flat textile formation is made from a multitude of cords or threads that are correspondingly oriented relative to each other and that are composed of a material that can be subjected to a heat treatment to print the desired shape. . Next, the flat textile formation substantially adapts to the inner surface of a forming element, whereby the extended state of the device is defined. Then, a thermal treatment of the flat textile formation is carried out in the extended state. Next, the flat textile formation is removed from the forming element. The cords or threads of the flat textile formation, in turn, are gathered at a common end point at the corresponding distal end and proximal end of the medical device. A corresponding procedure is also disclosed in the corresponding document EP1210919A2.

The implants mentioned above serve, among other things, for the treatment of vascular diseases, the vascular defects being treated by minimally invasive surgery. The point to be treated is not opened directly by operation, but rather instruments and implants are introduced through relatively small incisions in the groin or abdomen area. Especially for cardiological treatment, implants are introduced into the vascular system through catheters, especially through large crural veins. In the treatment of defects of the heart partition, interventional treatment offers, among others, the advantage that it is no longer necessary to open the rib cage or open by cutting the sensitive heart, difficult to immobilize.

Other implants and catheter systems for the placement of such an implant are described for example in WO97 / 28744, as well as in US5.108.420A, DE4222291A1, DE2822603A, WO96 / 01591, WO93 / 13712, WO95 / 27448, US5,433,727A, EP0474887A1. In WO93 / 13712 an implant for closing partition defects is described, which in the implanted state adopts a double cone or double disk configuration, the outer structures being formed respectively from wire elements not directly connected to each other. These are covered with fabric veils, the fabric veils being sewn together in a radius corresponding to the defect to be closed. The disadvantage of this system is that the implant consisting of a plurality of components requires a lot of assembly work.

In WO95 / 27448 an implant intended for use as a venous filter and used for a septum closure is described. Here, from a series of individual devices, a relatively elongated double cone is formed, the cones facing each other in one embodiment, like a bone, while in another embodiment, the cones are oriented in the same sense, similar to a muscaria amanita.

From US 5,433,727A an implant is known in which a kind of screen is placed in front of a partition defect and is secured, through the defect, with an opposite closure formed substantially by four loops made of a wire respectively, that are deployed when ejected from a catheter to prevent the implant from passing to the side of the screen.

EP0474887A1 discloses an implant in which two round or other polygonal shaped sealing veils, which are held by a corresponding circumferential flexible frame element,

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being joined, among other things, through a multitude of threads that must be pulled through the catheter to place the implant. To ensure the position of the two veils, a central ratchet closure is provided. Due to the very large handling work, the implant described in said document is very difficult to locate and also requires a complicated assembly and, therefore, very prone to errors.

According to WO97 / 28744 an implant is described which, when expelled from the catheter, automatically deploys thanks to a printed secondary structure and adapts itself, within a wide range, to the dimensions of the defect, by elastic forces. The stamped structure is pressed, by way of a double disk, towards both sides of the defect, against the surrounding area. The implant is formed by a series of wire-shaped elements, joined together by suitable joining procedures such as ultrasonic welding or brazing. In addition, the implant is provided with a coating attached to the wire-shaped elements.

From DE10000137A1 an implant is known which in the secondary form takes approximately the form of a double disk with a proximal disk element and a distal disk element, the environment of a defective opening between the disk elements being housed, being formed the support structure by a split pipe along a part of its length. Strips are formed along the split part of the length of the tube, the width of which can vary. The proximal and distal ends of the supporting structure are also configured as tubes where the different strips meet.

According to document DE19604817A1, it is proposed to provide an implant consisting of a plurality of wire-shaped elements, which at one end, at a junction point of the different wires, presents a device for displacement, for exact positioning within the body of the patient. Said displacement device may, for example, have a ball shape, if necessary, with a loop for receiving a guidewire, so that the screen can be positioned and implanted better at a right angle to the wall of the partition wall defect, even if The catheter is not arranged at right angles to the wall. At the other end of the wires or of the wire structure, the wire-shaped elements are joined together, for example by another ball, by twisting wires with or without eyelets, by indirect welding, direct welding, gluing, sewing, using a thread, a cap or eyelets with or without a hoop.

WO98 / 02100 discloses a helically wound stent to close the ductus arteriosus with a wire that for introduction into the human body can be introduced into an extended state (primary form) through a catheter and into the body it adopts a state of closure (secondary form), the wire forming a closing anchor piece and a helical anchor piece, as well as a straight junction piece. In the closing anchor piece, the wire takes the form of a series of turns that extend over the cross-sectional area of the cavity to be closed. The straight joint piece is formed by the wire itself as a joint between the two spirals. However, a fixed support structure is not produced by the respective spirals, so a failure of the implant or its unwanted displacement within the defect opening cannot be ruled out.

From US 5,433,727A an implant is known to close large defects in large hearts, such as atrial septum defects (ASD) and interventricular septum defects (VSD). The closure implant comprises a deployable foam resin disk, a coated and "X" shaped wire skeleton, applied on the foam disk, as well as an adjustable loop, arranged in the center of the wire skeleton.

In the state of the art, for example, from US 4,994,069, implants that are deployed in the form of a ball are also known. Implants that are spirally wound are also known, for example from DE19704269A1, or as a tube by WO92 / 14408, said tube being placed in a vessel being also spirally wound or helically shaped or forming loops. Another spiral implant is known from WO97 / 42881. A wound implant is known from DE3203410. Other spiral implants are known from DE4104702A1, EP1046375A1 and DD158084. There is no fixed support structure in any of these spiral implants. Nor does the implant according to EP0378151A2 disclose such a fixed support structure. In it, a wavy bent wire is placed forming bonds linked together. A fixed support structure, on the other hand, is formed, for example, by twisting several wires together. In the primary or base form there is a so-called stent that in the secondary form changes the relationship between the length and the transverse extension along an axis, making this relationship between the length and the transverse extension smaller than in the primary form (stent) WO98 / 47430 discloses a closing device according to the preamble of the first claim.

In the aforementioned implants it is disadvantageous that they either have a very complicated construction, or they are very complicated to implant in the human or animal body, or they do not allow a secure hold inside a vessel or other cavity inside the body. of the person or animal. It is especially difficult to move these implants in terms of their position in case they have been misplaced

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during the placement procedure. Especially the removal of implants from the patient's body is difficult due to its structure.

Therefore, the present invention has the objective of overcoming these disadvantages of the state of the art and especially providing an implantable device that is suitable both for the closure and for the partial closure of an organic route, a defective opening, a cavity etc. , as well as to provide a defined joint opening between walls, organs, cavities etc. within a human or animal body, that is to say, that it can be used in a variable way and also be removed again from the implantation site, that is, that it can be implanted and extracted.

The objective is achieved by an implantable device according to the preamble of claim 1, because the support structure is formed from a single wire-shaped element by cross-winding and / or twisting and / or braiding as a fabric and / or a nonwoven fabric and / or a net, and by the other features of claim 1. Some variants of the invention are defined in the dependent claims.

In this way, an implantable medical device is provided for the closure of vessels or the partial closure of openings or other cavities in the human or animal body, which is suitable for example for use in VSD and ASD. In addition, a defined joint opening is provided between the walls, the organs, the cavities etc. within the human or animal body. The device can be configured in a very varied way using a single wire-shaped element. Especially, it is possible to close openings in the area of heart valves, an area in which the implants currently known cannot be positioned due to the lack of unilateral space existing therein. Thanks to the use of only one wire-shaped element, the implantable device can be configured asymmetrically, especially with bilaterally open ends, especially unlike the state of the art mentioned above, in which at least one end of the finished implants This is especially due to the fact that a braid or weave of numerous wire-shaped elements is used there. In contrast to the implantable spiral-shaped devices of the prior art, in the device according to the invention a support structure is made which is much more stable and which can also take the most diverse forms, especially also non-symmetrical forms, which is not possible in the implantable helical or spiral-shaped devices of the state of the art. The support structure has a much greater resistance to the forces acting from outside and, therefore, can be implanted in the human or animal body more safely than the spiral or helical devices of the prior art.

The support structure is made by cross-winding and / or twisting of the wire-shaped element as a fabric, a non-woven fabric, a braid, a net or the like. Despite using a single wire-shaped element, such a support structure can be formed by winding, cross or braiding, the support structure having a fabric, non-woven and / or net structure. By means of the cross winding and / or the twisting or twisting of the wire-shaped element, in the primary form or the basic wound form there is substantially a tubular element. It has two open ends, preferably both ends of the wire-shaped element arranged at one of the ends of the support structure

or integrated into the surface of the support structure. Thus, on the one hand, the lowest possible risk of injury is achieved for the patient in which the implantable device is implanted, and on the other hand, a solid support structure itself. This is not possible with state-of-the-art helical implants, since their ends always end at the outer contour of wound discs or at the ends of the wound stents.

If the two ends of the wire-shaped element are incorporated by braiding on the surface of the support structure, they are secured so as not to be accidentally released. If the two ends of the wire-shaped element end at only one end of the support structure, the other end can be provided with a so-called perfect edge, that is, a uniformly shaped edge, substantially smooth, so that in said extreme, advantageously, there is no risk of injury to the tissue surrounding the implantable device. The same can be done by incorporating the ends in the support structure by braiding or by joining them. Of course, it is generally also possible that the two ends of the wire-shaped element protrude or are twisted at different ends or at different positions within the support structure and / or at one end.

Preferably, the proximal section and the distal section are made in the form of a disc with an intermediate section disposed therebetween, the intermediate section having a reduced diameter with respect to the proximal section and / or the distal section. Through this conformation, a particularly good fastening is possible in an opening within a wall in the human or animal body, since the disc-shaped proximal and / or distal sections can be deposited very well on both sides of the wall. Depending on how the intermediate section is configured, it can form either a defined passage opening, or a complete or partial closure in the wall. Preferably, the only one wire-shaped element initially forms, by winding, cross or torsion correspondingly, an elongated flexible tube with a woven, non-woven or net structure that is then contracted in terms of its diameter between the two ends of the flexible tube, and in the area of its

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Distal and proximal ends bulge outward so that there is a larger diameter than in the area of the intermediate section. After printing the secondary form, for example a narrow tube with two very large butt discs at its ends, a substantially flat formation may result. In a preferable embodiment, the two disc-shaped proximal and distal sections are substantially flat, although in other embodiments they may also be concave in shape or be redoubled so much that a formation with an interior space results. In the secondary form, at least one of the two proximal and distal sections is preferably redoubled in the direction of the other. Depending on the extent to which the two proximal and distal sections are redoubled with respect to each other or in which one of the two sections is redoubled with respect to the other, it results in a more or less pronounced mushroom or bowl shape, preferably with an opening of internal passage. Preferably, in the secondary form of the support structure there is a central passage opening in the implantable device for the partial closure of an opening in the human or animal body. By means of a partial closure of this type it is possible to produce a defined opening and, for example, to reduce a high pressure on one side of the implantable device to a reduced pressure on the other side. A field of application is, for example, the use in a blood vessel that leads to the head, to reduce by means of the implantable device the blood hypertension existing in the blood vessel, before reaching the head, especially in the area of the shoulders. One field of application is also the pulmonary artery in which an implantable device can be inserted for partial closure. In addition to a closure and a partial closure, an open connection can also be established between two walls or between organs between which a predetermined opening must remain. It is also possible to use in the colostomy.

Preferably, a passage opening provided within the implantable device is disposed eccentrically within it. The proximal section and the distal section may be offset relative to each other, so that the intermediate section and, in particular, the passage opening is not centrally arranged in the implantable device, but in an off-center manner. Precisely if the implantable device is used to close openings in the heart valve zone, this is advantageous, if a defined passage opening or intermediate section is disposed between the proximal section and the distal section in the marginal zone of the implantable device. In this way, despite the lack of unilateral space, the device can be implanted in a fixed and safe way. The arrangement of the passage opening or intermediate section can be chosen at discretion according to the field of application of the device.

Preferably, the dimensions and shape of the implantable devices, of a passage opening within the implantable device and / or of the edge of the implantable device can be chosen or adjusted according to each application case. Also the position of the passage opening within the implantable device or the support structure can be chosen according to the application case. For example, it can also be performed unilaterally in the marginal area of the device. Especially preferably, the amount of material in the marginal area of the implantable device can be adapted to the desired properties, a concentration of material in the marginal area of the device for partial reinforcement being especially provided. If an implantable device according to the invention has the largest diameter preferably in the marginal area of the proximal and / or distal section, said area is especially suitable for the selective adjustment and modification of the stability of the implantable device. When a concentration of homogeneous material has been generated by the surface of the implantable device, it presents substantially everywhere the same flexibility and, therefore, the same deformability. If a fixed support is to be produced, for example within a blood vessel or within another tube within the human or animal body, the marginal area of the support structure can be made especially stable by a concentration of material in this place. In the area of the remaining surface of the support structure, however, greater flexibility and deformability is then maintained. If, especially within a blood vessel or another tube within the human or animal body, a definite step is to be taken, an annular form can be formed from the primary tubular form or the basic wound form as a secondary form, especially the whole material being concentrated only in the marginal zone, so that a very stable ring is produced. Generally, a membrane can be placed inside it, so that a closure of an opening is also possible in this way. Precisely because of the concentration of material in the marginal zone, a so-called "perfect edge" can be formed there. This is characterized in that it is substantially flat, that is, no loop or loops protrude. In this way, a particularly good support is possible and with a risk of injury especially low inside tubes, especially blood vessels or other organic pathways in human or animal bodies.

Preferably, at least a partial area of the implantable device is configured foldable or folded. Preferably, in the secondary form, the proximal section and the distal section of the support structure are placed flat and partially on top of each other, so that a partial closure or closure of openings limited laterally by walls is possible, especially in the zone of valves in the human or animal body. In the primary or basic wound form of the implantable device, it is preferably also tubularly shaped and, only in the secondary form, is it folded either unilaterally or at several points, and can be configured at discretion, the entire device being preferably configured implantable or support structure flat in the secondary form. However, it is also possible

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Flatly configure only partial areas, namely those that are folded over each other. By folding a part or the entire support structure, conformations are possible that can also be positioned at points that cannot be accessed with conventional implants. It is especially advantageous that the entire implantable device can be substantially flat.

In addition, at least in one section of the support structure, symmetrical or irregular configurations are possible in the primary and / or secondary form. Therefore, there should no longer be any rotational symmetry that was customary in the implantable devices of the prior art and, because of the structure, was substantially the only possibility. It is especially preferable that the concentration of material and / or the thickness of material varies by sections within the support structure. Therefore, the wire-shaped element can also have different thicknesses of material in itself, that is, different diameters. Alternatively or additionally it is possible to provide more than a single wire to form the support structure, said wire being able to be partially bent or reinforced. Also in this way, selective concentrations of material can be achieved at certain points, so that the support structure is configured more rigidly or less rigidly by parts. There are great possibilities of variation, since for a given application case a specific form can be selectively adjusted and adapted in terms of its rigidity specifically to the application case. If only one symmetric or asymmetric structure can be housed on the distal or proximal side, it is also possible to configure a section so that in one direction no extension or substantially any extension of the support structure is achieved, while the other section present an extension in all directions. In this way, at least unilaterally, an especially good fastener can be produced in an opening, which does not offer space for a uniformly configured implant to the other side.

Preferably, the end of the proximal section is open or closed partly or completely, especially by providing a plate element. With the support structure of a single wire-shaped element being realized, the end of the proximal section preferably has one or more loops or ties arranged next to each other and / or in a cross-linked and / or interlaced form. A substantially homogeneous edge can also be formed, if the loops or loops are intersected with each other elongated. An edge of this type is suitable precisely in proximal and distal sections in the form of a disk. For example, if the proximal section forms a short tubing within the surface of the distal section, the proximal section preferably has loops or loops at its end. These surround a passage opening, and may preferably be arranged as loops in the form of " e " next to each other or as ties in the form of "or" next to each other or interlaced with each other for the exact delimitation of the passage opening, or in a cross-linked or interlaced manner between them in one and / or the other way, so that in the latter case, the passage opening substantially closes. A complete closure can be carried out especially by means of a fixing plate as a plate element. This can be joined there, for example, by gluing, sewing, welding etc.,

or be incorporated, for example, threading the loops at the end of the proximal section.

Preferably, the distal section and / or the proximal section is substantially bent flat in a disk or ring shape or at least in the marginal area, or is bent towards a distal and proximal intermediate section of junction, delimiting an interior space. Depending on the extent to which the proximal section or the distal section is bent or redoubled, a caliciform formation results in lateral elevation or, if necessary, even a formation completely redoubled on one side or both sides (proximal and / or distal), whose end (s) enters a central passage opening. An interior space is delimited respectively by the distal and / or proximal section redoubled in this way, while still maintaining the advantage of a substantially flat configuration. Obviously, separating the distal section and / or the proximal section can also cause an increase in the direction of the axis passing transversely through the implantable device. This can also be adjusted variablely at discretion depending on the case of application.

Preferably, the support structure is formed as a unit of two or more joined parts forming a piece, from a wire-shaped element. However, it can also be composed of a continuously wound formation in one piece. Particularly preferably, the different parts of the support structure are made in a homogeneous manner, corresponding to each other or differently. Since, preferably, a continuous flexible tube or a similar element is not formed, but several chained parts, substantially without interruption between the different parts, a greater rigidity of the support structure is achieved. In addition, a special additional reinforcement is possible in the part chaining area of the parts. In addition, the different parts can be configured differently, with gaps being possible in part between the different parts. In this way, during the conformation to the secondary form, special effects can be achieved, and secondary, non-symmetrical or asymmetrical forms can be produced. In addition, support structures can be made with a stiffness that varies along the cross section. If a support structure that is stent shaped in the primary form or the basic rolled form is made with loops on the distal side and openings or gaps in the structure, it could also be used to collect objects in organic pathways or in body organs or openings . The different sections of the basic rolled form can also present

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different winding angles, so that areas of different stiffness can also occur.

Preferably, one or more membranes or membrane-shaped or membrane-forming structures may be introduced into the support structure or applied thereto. Preferably, the membrane-forming structure is formed by interweaving at least one thread, especially a thread of a flexible braid material, especially of a plastic, a regenerative raw material or metal. In a particularly advantageous way, dacron threads can be interwoven into a support structure formed of nitinol and / or a fabric, a non-woven fabric, a braid or the like can be formed from these threads and incorporated into the support structure. Alternatively or additionally, carbon fibers are also suitable. Through these fibers or threads, a passage opening that passes through the implantable device can be closed. By providing membranes, membrane-shaped structures or membrane-forming structures in the support structure, a total closure can be made, for example, of defective openings in the body of a person or an animal. Depending on the configuration and arrangement of the membrane within the support structure, a partial closure can also be performed. As already mentioned above, a membrane or membrane-forming structure of this type can also be incorporated in a secondary secondary form of the support structure, so that, depending on the flexibility of the membrane or membrane-forming structure, a formation results which moves flexibly to some extent, but is fixedly incorporated in an organic way. Membranes of this type can be textile, woven, braided or similar nonwoven fabrics or even integrated into the wire, woven or cross-shaped element of the support structure. A combination of the two possibilities is also possible. For example, it is possible to subsequently weave at least one thread to form a membrane structure. The wire or the material of the membrane forming structure preferably differs from the wire-shaped element, although it can also have the same cross-section. Preferably, the membrane-forming structure is composed of a material with a thinner cross-section or has a braid, a non-woven fabric, a fabric with threads of different diameters. In order to achieve different seals within the membrane forming structure, the thread or the material of the membrane forming structure preferably has different diameters per se, or several parallel extension wires are provided. Alternatively, the membrane-forming structure may also be formed preferably by immersing the support structure in a film-forming material. Such a material may be especially a natural or synthetic polymer, formed by one or more monomers, especially formed by polyaddition, polymerization or polycondensation, especially a polycarbonate, a polyester, a polyamide, a polyolefin or polyurethane. Polystyrenes are also suitable. Depending on the case of application, a material that presents a greater or lesser flexibility or surface tension and that does not cause rejection processes in the human or animal body is preferably chosen. Depending on whether something is to be deposited on the membrane-shaped structure, for example fabric, the choice of material can be focused on hydrophobic or hydrophilic materials. It is also possible to cover the membrane-forming structure and / or the threads of a membrane with this type of materials.

Preferably, the membrane-forming structure or the membrane is formed by a fabric, a non-woven fabric or other textile, and provided in the marginal area with cantilever arms for threading and / or fixing to the support structure, especially by sewing , gluing, welding, crimping or other fixing procedure. In this, especially the cantilever arms are passed around the marginal area of the support structure at the distal and / or proximal end and are attached to the surface of the membrane-forming structure or the membrane and are fixed there. In this way, a particularly good and slip-proof fastening on the support structure is possible.

The membrane or membranes, the membrane-shaped structure (s) or membrane-forming (s) is preferably disposed on the proximal and / or distal side and / or substantially centrally within of the support structure. The membrane (s), the membrane-shaped structure (s) or membrane former (s) can also be arranged obliquely within the support structure, that is, for example, from the side proximal to the side distal, if appropriate for the specific application case. It is also possible only a partial arrangement thereof within the support structure, especially to make a partial closure possible.

Preferably, the material of the support structure is chemically and / or mechanically treated in at least a partial area, especially by corrosion, electropolishing, micro grinding or other treatment. In this way, different thicknesses of material and, therefore, different rigidities can be produced. Such a treatment is especially suitable in a cut tube. Especially preferably, the wire-shaped element or the cut tube of the implantable device is composed of a biocompatible material, especially a metal or a metal alloy, especially a stainless steel or a shape memory material such as nitinol. or a plastic such as polycarbonate. Preferably, a material is used with which it is possible to configure different primary and secondary forms that are printed on the material such that when the implantable device is placed inside a human or animal body it automatically adopts the secondary form or that a possible discretionary change between the primary form and the secondary form, especially using additional auxiliary means. To achieve compatibility with the animal and / or human body is used,

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especially, a biocompatible material. From polycarbonates structures can be formed, especially by laser cutting, which resemble fabrics, nonwoven fabrics or nets. By applying a suitable film material, a membrane as described above can also be provided in such a support structure. By means of a laser cut, greater flexibility is possible than in the case of cross-linking or twisting of a wire-shaped element. Especially a support structure formed by polycarbonate also has a good ability to fold. In this way, the transport to the implantation point can be carried out in a particularly little problematic way. The same applies to carbon fibers. From these, the support structure can be made, especially also by sewing. By immersing the support structure made of polyurethane, a shape memory structure can also be made. Using carbon fibers or polycarbonates can suppress the use of metals that in part are not tolerated very well by patients.

A detection of the position of the implantable device during the implantation procedure can be carried out advantageously by radiography or by 3D ultrasound. If a metallic material is used for the support structure of the implantable device, an X-ray detection can be advantageously performed, while in the case of using a polycarbonate to perform the support structure and / or drainage threads and / or fibers Carbon to make a membrane or the membrane-shaped structure is a 3D ultrasound suitable for detection.

To place the implantable device inside the human or animal body, preferably, a placement system is provided. In this, preferably, the fastening wire (s) can be threaded or threaded through one or more loop (s) or loop (s) at the end of the section and can be joined with the guide wire and / or the inner mandrel . It is also possible to arrange the clamping wires at the distal end.

In particular, a clamping wire can be threaded through all loops or loops at the end of the proximal section. In an alternative embodiment, for example, two fastening wires can be threaded through all or several of the loops or loops at the end of the proximal section, arranged in one half thereof, the inner guide wire or mandrel extending preferably to through a loop between the two clamping wires, formed by them, so that there the clamping wires have a fixing point. When the guide wire or the inner mandrel is removed from said loop, then the clamping wires can also be removed, so that the proximal section can be fully deployed in said area. Alternatively, several clamping wires can also be threaded through several loops or loops at the end of the proximal section, the clamping wires preferably being always threaded through a portion of the loops or loops. For this purpose, any number of fastening wires can be provided, especially also a fastening wire for each loop or loop, preferably forming a chain of fastening wire loops and passing the inner guide wire or mandrel preferably through only one loop at the end of the chain of wire ties.

Once all the loops or loops have been assembled at the end of the proximal section, it may be sufficient to provide a single clamping wire with a loop and an inner guidewire or mandrel that is passed through said loop. For example, 1, 2, 10, 12, 18, 24 or any other number of loops or loops may be formed at the end of the respective proximal and distal sections, through which a discretionary number of fastening wires can be threaded .

To place the implantable device in a place within the human or animal body, a catheter is preferably used, as well as a feed tube, especially a guide wire and a holding wire or holding wires. First of all, the loops or loops at the end of the proximal section and especially also of the distal section are threaded by one or more clamping wires, and the guide wire is positioned such that the clamping wire is encased therein, thereby substantially preventing it from being released early from the implantable device. Next, the feed tube is positioned on top of the guide wire and the clamping wires and the implantable device is pulled into the feed tube during which it takes an elongated shape. The catheter is inserted into the patient's body, during which the feed tube is preferably already inserted into the catheter or will be introduced next. The catheter is advanced until it is positioned in the area of the point where the implantable device is to be placed. Then, first the feed tube and then the guide wire together with the implantable device are ejected from the catheter and then from the feed tube and placed at the point where it should be positioned.

With the positioning system it is also possible to remove an implantable device from the patient's body again. This may be convenient or necessary after a wrong positioning or once it has been cured. In the location system according to the invention, for this purpose the extraction of the implantable device from the implantation site in the human or animal body, preferably, a guide wire and an extraction wire are provided, the extraction wire can be laid forming a loop can be threaded through at least one loop or loop at the end of the support structure. For the procedure of

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extraction, preferably, at least one loop of the at least one extraction wire is passed through the implantable device. The guidewire is also passed through the implantable device and through the loop of the extraction wire. When pulling the extraction wire and the guide wire, the loop is held in the guide wire, in any case if the guide wire and the extraction wire have not taken the same path through the implantable device. By pulling both wires, the implantable device can be pulled into a catheter and, if necessary, completely removed from the implant site. A change of position is also possible in this way.

Preferably, a set of several implantable devices formed in different ways is offered, together with at least one clamping wire and / or an extraction wire, both of which can be made in the same way, a guide wire and / or an inner mandrel. and, if necessary, a catheter. In particular, the catheter and the holding wire or the extraction wire and the guide wire and / or the inner mandrel can also be used several times, while the implantable device usually remains within the patient.

Alternatively or additionally to the site system described above, it may have an advancing element, an auxiliary structure that in a first operating state (primary form) has a large relationship between the length and the transverse extension along an axis and in a second operating state (secondary form) it has a smaller relationship between the length and the transverse extension along the axis and is intended to encourage the deployment of the proximal end of the support structure and at least one joining device for join the proximal end of the implantable device and the distal end of the auxiliary structure. If problems arise during deployment of the proximal end of the support structure, these can be remedied by providing such an auxiliary structure. The auxiliary structure is joined at its distal end with the proximal end of the support structure and, next to it, is taken to the implantation point, for example through a catheter. After deployment of the distal end of the support structure, the proximal end of the support structure and the distal end of the support structure attached to it are deployed. The distal end of the support structure is configured such that during its own deployment it unfolds the proximal end of the support structure. Using such a positioning system, the support structure can be positioned exactly and in such a way that after its launch no movement is substantially allowed. Preferably, the joining device has at least one clamping wire, especially three clamping wires. To join the two structures, just use a single clamping wire. If three clamp wires are used, a clamp and a withdrawal is possible without having to invest virtually no force. Preferably, the at least one clamping wire can be threaded or threaded through one or more loop (s) or loop (s) at the end of the proximal end of the implantable device and the distal end of the auxiliary structure. Thus, in the path to the implantation point, a good connection between the structures and an easy removal of the at least one clamping wire is possible after the fastening of the proximal end of the support structure.

Preferably, the ends of the wire-shaped element are properly joined together to reduce the danger of injury to the patient. Especially preferably, a bushing or a tubular element is placed on the ends and fixed there especially by compression or gluing. In addition, another element, such as a spiral or similar, can be placed on both ends. Direct bonding is also possible, especially by direct welding, indirect welding, twisting or gluing or the like.

The implantable devices according to the invention can therefore fulfill various functions. On the one hand, they can be introduced into the patient's body through a catheter, and serve for closure, partial closure or the provision of a defined passage opening. They are not annoying for other structures within the patient's body, they can be implanted and they are held by themselves at the implantation site after being deposited, although if they are bothersome or if an incorrect positioning has occurred, they can be removed again from the point of implantation. Until now, the implants were provided with a supporting framework to be stable. The implantable devices according to the invention already have sufficient stability by their conformation which also allows them to put themselves in the desired position. They are no longer necessarily symmetrically configured and, therefore, can be configured specifically according to the point of implantation and positioned there by themselves in the correct orientation.

For a more detailed explanation of the invention, some embodiments are described in detail below with the aid of drawings. They show:

Figures 1, 1a, a plan view from above and a plan view laterally from above of a first embodiment of an implantable device,

Figure 2, a top plan view of a second embodiment of an implantable device,

Figures 2a to 2d, sectional views of different embodiments of a variant of the embodiment according to Figure 2,

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Figures 3, 3a, a plan view from above and a side elevation of another embodiment of an implantable device in which a passage opening is arranged asymmetrically,

Figures 4, 4a, a plan view from above and a side elevation of another embodiment of an implantable device having a folded partial area,

Figure 5, a top plan view of another embodiment of an implantable device having an irregularly shaped distal section,

Figure 6, a plan view from above of another embodiment of an implantable device with a marginal area of the distal section with a concentration of material and with a proximal section configured in a very short way that has adjacent loops at its end,

Figures 6a to 6d, detailed views of other variants for the configuration of the proximal section of the implantable device according to Figure 6,

Figure 7, a top plan view of another embodiment of an implantable device according to the invention, the proximal section being redoubled towards the intermediate section,

Figures 7a to 7c, other variants of the embodiment according to the implantable device according to the invention according to Figure 7,

Figures 8a to 8e, side elevations of embodiments of basic winding forms of an implantable device according to the invention which is made in two joined parts, made of a single wire-shaped element,

Fig. 9, another embodiment of an implantable device, in which it is made up of several parts arranged side by side or inside each other, from a single wire-shaped element,

Figures 10a to 10c, schematic views of different configurations of the marginal area of a distal section,

Figures 11a to 11e, plan views from above of different embodiments of implantable devices that are provided with membranes or membrane-shaped or membrane-forming structures,

Figure 12, a plan view of another embodiment of a membrane for an implantable device according to the invention,

Figures 12a, 12b, plan views from above of membranes incorporated in support structures, according to Figure 12,

Figures 13a to 13g, the development of the location of an implantable device,

Figures 14a to 14c, detail views of proximal section ends of implantable devices in which clamping wires and guidewires of a positioning system according to the invention are arranged,

Figure 15, a detail view of one end of an implantable device with an extraction wire and a guide wire,

Figures 16 to 16c, plan views from above of embodiments of final fasteners of the ends of a wire-shaped element,

Figures 17a to 17e, a schematic representation of the development of the development of an implantable device,

Figures 18a to 18j, a schematic representation of the development of an alternative embodiment of the location of an implantable device,

Figures 19a and 19b, perspective views of two steps of the location by means of the location system according to Figures 18a to 18j, and

Figure 20, a schematic view of the threading of fastening wires in the positioning system according to Figures 19a and 19b.

Figure 1 shows a plan view from above of a first embodiment of an implantable device 1. This is composed of two proximal and distal sections 20, 30 in the form of a disk and an intermediate section 40 arranged between them. A passage opening 50 is provided within the intermediate section. As can be seen in Figure 1a, which represents a plan view from the side of the embodiment.

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according to Figure 1, the two proximal and distal sections 20, 30 are arranged respectively not symmetrically with respect to the intermediate section, but with a displacement between them and with respect to it. Therefore, the passage opening 50 is not centrally arranged in the two proximal and distal sections. The intermediate section 40 is formed in such a way that a primary tubular shape of the implantable device 1, by twisting or turning, is divided into two parts, namely the proximal and distal sections 20, 30. Next, the proximal and distal ends of these sections are pulled or folded out until the disc-shaped sections are formed. In the outer marginal zone 21, 31 of the distal and proximal sections, when using a single wire-shaped element 10 for the entire implantable device, loops 22, 32 are formed. Such loops can be used to thread fastening wires during placement in the place within a human or animal body in which the implantable device has to fulfill its function, namely a total or partial closure of defective openings, cavities, organic pathways etc. or a defined joint opening between walls, organs, cavities etc. As indicated in Figure 1a, the implantable device 1 is positioned and deployed after being placed in such a defective opening 2, for example in a wall 3 of a person's heart.

The embodiments of an implantable device 1 shown in Figures 2 or 2a to 2d differ from that shown in Figure 1 especially in that they do not have such a flat construction and can also be implanted especially well in vessels for reduction of pressure. The embodiments represented in said figures are made each and every one of a single wire-shaped element 10. In the embodiment represented in Figure 2, the proximal section 20 is redoubled in the direction of the distal section 30 of so that a crown shape with an internal passage opening 50 results. The distal section is substantially cylindrical. Also the second half of the proximal section ends substantially cylindrically. During implantation in a vessel or other tubular organ, only a partial closure occurs and through the passage opening 50 the passage, for example, of blood or other body fluid, is still possible.

In the embodiment according to Figure 2a, both the distal section 30 and the proximal section 20 are bent towards each other. In this way, a flatter formation results than in Figure 2. The extent to which the distal and proximal sections are bent towards each other can be chosen at discretion specifically according to each application case. At the ends bent towards each other of the distal and proximal sections an even better spring effect is achieved in the transverse direction in said area and, therefore, during the introduction into a vessel an even better grip is achieved than is possible. for example, with the embodiment according to figure 2. The embodiment according to figure 2b has a substantially flat proximal section 20 and a distal section 30 bent thereto. In turn, between the two is the passage opening 50, the intermediate section 40 being longer and more cylindrical compared to Figure 2a. In this embodiment, as regards the lateral circumferential extension, the proximal section protrudes from the distal or contour section formed by the circumference of the distal section.

In the embodiment shown in Figure 2c, the distal section in turn is bent towards the proximal section, but the intermediate section 40 is shorter than in the embodiment according to Figure 2b and neither is the proximal section bent towards it was substantially disk-shaped, but it is only slightly bent, describing a smaller circumference and a smaller diameter than the end of the distal section. The embodiment represented in Figure 2d constitutes substantially an inversion of the embodiment represented in Figure 2, since in this embodiment according to Figure 2d, the distal section 30 is redoubled towards the proximal section 20, while The proximal section remains substantially cylindrical.

In Figures 2 or 2a to 2d it can be seen that numerous variants are possible in which the distal section and / or the proximal section are redoubled respectively towards each other, leaving a passage opening 50 between the sections. Therefore, a partial closure or an open joint of defined diameter between two walls or within a vessel is possible. In all the embodiments depicted in Figures 2 to 2d, a special force is provided for fixing the device 1 within the patient's body, which at the same time is sufficiently elastic, so that organic tracks or moving vessels can be provided. of an implantable device 1 of this type without the risk of it moving in an unwanted way within the vessel or the organic path. Rather, the implantable device 1 is fastened particularly well inside.

Figures 3 and 3a show another embodiment of an implantable device 1. Figure 3 shows a plan view from above and Figure 3a shows a side elevation of the device 1 in a state inserted into a wall. The passage opening 50 is arranged eccentrically in the marginal zone 21, 31 of the proximal section and the distal section. The proximal section and the distal section are arranged on top of each other substantially flat and more or less congruent. The marginal zone 23, 33 directly adjacent to the passage opening 50 of part of the proximal section and of the distal section is made with a greater concentration of material. This means that in this area the width of meshes of the loops or meshes formed by the wire-shaped element is smaller, so that said marginal areas 23, 33 are more rigid than the other marginal areas 21, 31 of the distal sections and proximal.

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In Figure 3 it can be seen that the passage opening can be arranged at any point of the implantable device, which can also have a variable diameter at discretion, that also the concentration of material can vary along the cross section of the implantable device, especially of the proximal section and of the distal section, especially in the marginal zone, and that the width of meshes and the circumference and size of the proximal section and of the distal section can be adapted to the application case and can be varied at discretion. Especially in a comparison with Figure 1, it can be seen that the diameter of the passage opening 50 is larger in Figure 3, so that a partial closure occurs if inserted into a defective or similar opening in the body human or animal

However, as still described below, each of the passage openings shown in the preceding and subsequent figures can be closed to a greater or lesser extent with a membrane or with a membrane-shaped or membrane-forming element or with Such a structure. In this way, a total closure is also possible, even if the passage opening is large.

As can also be seen especially in Figure 3, a border can be formed by loops 22, 32 and / or an edge designated as "perfect edge" in which the different loops are arranged close together on each other, so that in the case represented in figure 3, therefore, a greater concentration of material in the marginal zone 23 and 33 results. In this way, they can be changed in It starts the mechanical properties of the marginal zone and, therefore, also of the implantable device 1 as a whole. As can be seen especially in Figure 6, an annular zone can also be formed around the whole implantable device, which has a high concentration of material and, therefore, greater stability than the remaining area of the implantable device.

Another embodiment of an implantable device is shown in Figures 4 and 4a. In this, a partial area 29 of the proximal section is folded in such a way that a very flat formation results. On the proximal side, therefore, the section is duplicated. Between the proximal section and the distal section, there is a partial groove part in an overlapping area 41 into which a wall 3 can be introduced, for example, to fix the implantable device thereto (see Figure 4a). Despite the fact that the implantable device is configured very flatly, a total closure of a defective or similar opening is possible, since the intermediate section 40 is closed on the proximal side (Figure 4a). This embodiment is suitable, for example, also to be inserted in the area of a cardiac valve, since the device 1 can be folded at discretion in the proximal section and / or the distal section, so that an optimal adaptation to the conditions is possible of unilaterally reduced space in the area of a heart valve. Therefore, the extent to which the respective proximal and / or distal section is folded can be decided depending on the specific application case. Completely irregular support structures may result that can then be optimally adapted to local and space conditions.

In the embodiment shown in Figure 5 an irregular support structure is also formed. This plan view from above shows in its upper area the distal section 30 and in its lower area the distal section 20. The distal section is formed substantially only by loops 32. However, these loops are arranged only in an area that covers approximately 250º of the circumference. A loop of this type is not arranged in the remaining circumferential zone. In the case of the proximal section it is different. This shows, in Figure 5, loops 22 in the area generally indicated by arrow 60. Towards the opposite side of arrow 5, indicated by arrow 61 in Figure 5, only a few loops are formed in the proximal section. This allows therefore, an especially good fixation of the implantable device 1 in the proximal area. In the distal section, due to the lack of the loop or loops in zone 60 it is possible to adapt to a possible protruding organ or to any other obstacle in the human or animal body, although optimal support is also possible on the distal side , since the distal section allows a good fixation in the direction of arrow 61.

Other embodiments of the implantable device are shown in Figures 6, 6a, 6b, 6c and 6d, with Figures 6a through 6d respectively showing only detail views of the proximal section. The fixing side or the fixing side itself is in turn the proximal end 24. This is made very shortly in Figure 6 and constitutes substantially only an intermediate section 40 pulled slightly outwardly surrounding the passage opening 50. The distal section is provided with a "perfect edge" in the marginal zone. Overhanging the wire-shaped element 10 of which the support structure of the device 1 as a whole is represented is shown. The end 11 of the wire-shaped element 10, which protrudes from the marginal zone 31, is interwoven there. However, for clarity, here it is pulled out. The other end 12 of the wire-shaped element 10, preferably, is also interwoven in said marginal zone or on the surface 35 of the distal section.

In the embodiment shown in Figure 6, the proximal end 24 is made with adjacent overlapping loops. In an area 62, only three loops are arranged side by side without being intertwined or covering each other in the marginal zone. Therefore, here, the marginal zone of the proximal section is also irregularly made. However, alternatively it can also be done on a regular basis, as

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indicates for example in figure 6c. In this, the ties 22 are arranged respectively next to each other. Alternatively, loops 26 can also be formed in the form of "and" as indicated in Figure 6b. These can also be arranged next to or above each other. A passage opening 50 is made by the embodiment according to figure 6d in which the loops are arranged one above the other delimiting the opening 50. Both in the embodiment according to figure 6b and in the embodiment according to figure 6c or 6d, there is still a passage opening 50. However, if the different loops 26 or loops 22 in the form of " e " they intertwine completely with each other, there is no longer any passage opening in the center or inside the proximal section or, therefore, the distal section (Figure 6a). In this area, a fixing plate can be additionally arranged to ensure a better fixation within an opening in the human or animal body. The fixing plate can be placed, for example, on one side of a defective opening. In this way, a complete closure of an organic route, of a defective opening or the like is also possible.

In another alternative embodiment, only the marginal zone of the distal section and the proximal section remains. A ring of this type can be seen as a support structure for a membrane in Figure 12b. The proximal section is so pulled out that it is in the area of the diameter of the distal section. Here, it is a very stable ring that can be provided with an inner membrane or inserted as a means of reinforcement, without such a membrane, in an organic or similar route in the human or animal body.

In FIGS. 7, 7a, 7b and 7c, other embodiments of the proximal section 20 are shown. The respective distal section is substantially disk-shaped. However, in an alternative embodiment, it can also be configured correspondingly to the proximal sections. Figure 7 shows a side elevation of an embodiment according to the invention, with a proximal section that is initially pulled out in the form of a disk and then again bent inward, presenting at the proximal end 24, in the passage opening area, interlocking ends of loops and loops. A passage opening 51 is formed only in the area of the distal section 30 and the intermediate section

40. It ends within an interior space 27 formed by the proximal section 20.

The embodiment according to Figure 7c differs from that of Figure 7 in that the proximal end 24 of the proximal section 20 is not completely closed, that is, the loops and loops that end there are not mutually covered, but leave an opening 52 between them. In addition, the proximal section defines an interior space

27. The passage opening 51 that begins in the distal section 30 continues, through the intermediate section 40, to the opening 52 in the proximal section. If the openings are not closed by a membrane, a partial closure is now possible after implantation of this device 1.

An even better flow of fluids is possible by the device 1 shown in Figure 7b. In this, the edge of the proximal section, that is the proximal end, is not contracted to the passage opening. Rather, the proximal section is simply formed in such a way that it is first shaped outwardly in the form of a plate from the intermediate section 40 and then is again pulled a little inwards by the edge. This marginal zone 28 resembles a flange. No interior space is already defined or is only delimited in that marginal area. An even more extreme form in this regard is represented in Figure 7a. Here, the proximal section in turn is substantially bent only in the form of a plate and only very slightly outward on the proximal side. The distal section is also bent out on the distal side. This can also be done differently along the circumference of the distal section, as indicated in the marginal zone 36 in Figure 7a. Here, the edge is folded only in a partial section of the edge, so that a flange is partially formed in the circumference of the distal section.

Figures 8a to 8e show respectively variants of basic wound forms of the support structure of an implantable device 1 according to the invention. The basic wound forms are substantially tubular and are made from two halves joined using a single wire-shaped element 10. In a connection area 42 the two halves are joined using respectively a single wire-shaped element 10. Of this Thus, in said connection zone 42, greater rigidity of the basic wound form is achieved. This can be especially advantageous in certain cases of application, because even after the conformation to the desired secondary form, a good grip in this area is possible. For example, with a joint by means of a simple compression in the direction of the longitudinal axis 63, in figure 8a an annular support structure can be produced which in the marginal zone has mutually overlapping ties in the marginal zone, both on the proximal side as on the distal side. In the area between the proximal side and the distal side or its ends, that is to say in the connection area 42, a crown of protruding ties also protrudes from the ring. These loops of the chained ends of the joined halves, which later protrude, can be seen especially well in the detail view in Figure 8a. In addition, numerous other conformations are possible as secondary forms, as shown for example in the previous and following figures. According to Figure 8a, the two ends 11, 12 of the wire-shaped element leave the basic tubular wound form on one side.

Figure 8b constitutes a variant with respect to Figure 8a, the second half of said

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device only halfway, that is to say that the wire-shaped element 10 is wound in such a way that in this case the distal section 30 is already only partly made from the connection zone 42. Vice versa, the partly wound area can be also the proximal section. Any other configuration can also be made. For example, the two sections 20, 30 may be configured only in part. The conformation depends especially on the respective form of application or the secondary form to be performed. If desired, in the connection area 42 a reinforcement can be provided by means of a corresponding winding, which allows a good hold at the point of implantation.

Figure 8c shows a symmetrical configuration of the basic wound form, that is, the two halves, that is, the proximal and distal sections 20, 30 are symmetrically wound with respect to each other. Preferably, the winding process is performed in one pull, without performing two halves. Another variant is shown in Figure 8d in which two halves made together from a wire-shaped element are provided as a basic wound form. The two halves, that is to say the proximal and distal halves 20, 30, respectively have different angles regarding the winding direction. The angle in the distal section 30 is here of approx. 180º, while the winding angle in the proximal section is approximately 90º. Obviously, other angular values are possible at discretion. In the connection zone, these two halves are joined forming a piece, using a single element 10 in the form of wire for the whole of the basic rolled form.

Another variant is represented in Figure 8e. Here, the two halves of the basic winding form that form the proximal and distal sections 20, 30 are joined in such a way that during the winding process an inversion of the winding direction is provided in the connection zone 42. This can be seen better in detail view in figure 8e. Also here, as in the embodiment according to Figure 8d, especially as regards the rigidity of the secondary form of the support structure, special effects can be achieved, especially only partial stiffnesses of the support structure are provided.

Figure 9 represents another variant of such a support structure of a device 1 composed of several parts, which is not part of the invention. In this case, the first part, here for example the proximal section 20, is cylindrically shaped; intermediate section 40 is substantially cylindrical shaped, but has some gaps. The distal section 30 is made up of only four ties joined together, so that there are large openings 37. If the device is used to collect objects inside the human body, for example stones etc., they can be used to grab and hold these objects. This embodiment according to Figure 9 shows that individual sections formed together by a single wire-shaped element can be joined together at their discretion. Then, the two ends 11, 12 of the wire-shaped element are output only from one side, especially at the proximal end of the proximal section. In this way, the danger of injury to the patient can be maximized. Alternatively, however, the ends may also be woven into the lateral surface, for example, of the proximal section or of the other sections.

Figure 10 shows in its parts a, b and c respective configuration possibilities for edges of the distal section and the proximal section. Here, the loops 22, 32 can be crossed respectively with the adjacent loops (figure 10a), be crossed in an elongated way with the adjacent loops (figure 10b) or be configured in the form of "e " (figure 10c). Numerous intermediate forms are also possible. The choice of the shape of the border can be made depending on the respective application case.

Different embodiments of implantable devices 1 according to the invention having membranes, membrane-forming or membrane-shaped structures are shown in FIGS. 11a to 11e. Figure 11a shows a top plan view of a tubular basic wound form of an implantable device 1 produced from a single wire-shaped element, in which an additional wire 70 is interwoven in the support structure of the device. 1. Since the material thickness of the wire-shaped element 10 and the wire 70 differ strongly, the wire 70 being much thicker than the wire-shaped element, an especially dense membrane-shaped structure can be formed. If such a primary form, as represented in Figure 11a becomes a secondary form, for example, the variant represented in Figure 11 can be produced. This substantially resembles that shown in Figure 1. However, unlike this, the variant shown in Figure 11b is substantially impervious to fluids. Especially also in the area of the passage opening 50, because the thread 70 forms a membrane by the braid with the wire-shaped element. According to the material chosen for the thread 70, in this way, for example, a defective opening in the heart of a person can be closed and, if necessary, tissue can even grow therein.

An alternative to the total closure of the support structure formed by the wire-shaped element 10, by means of the wire 70, in which only a partial area is interwoven therewith, is represented in Figure 11c. Here, the passage opening 50 is especially closed, so that, if necessary, a complete closure of a smaller defective opening is also possible compared to the dimensions of the device

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implantable On the other hand, this embodiment variant, however, can also be used for the partial closure of defective openings, because the twisted wire is arranged only in zone 71.

In another alternative embodiment as shown in Figure 11d, no yarn is braided in the support structure, but instead a fabric or nonwoven fabric is inserted as a membrane 72. In the embodiment variant represented in FIG. 11d, said membrane 72, however, does not fill the entire surface of the distal section and the proximal section of the device 1, but leaves a marginal area 38 (in the case shown) in which no membrane is arranged. In the case shown, the latter is integrated only in the proximal section, although an alternative embodiment can also be integrated in the distal section, in which case also a marginal area not covered by the membrane can remain in the proximal section.

In another alternative embodiment as shown in Figure 11e, both the proximal section and the distal disk-shaped section are provided with such a membrane 72. The two proximal and distal sections are arranged with a displacement relative to each other, that is, the intermediate section with the passage opening is not centrally arranged in the two proximal and distal sections, so that the two membranes also overlap only in part, seen in plan from above. This is intended to show that it is possible to apply membranes discretionally on the support structure of implantable devices.

Other embodiments of a membrane 73 made according to the invention are shown in Figures 12, 12a and 12b. It has 74 cantilever arms distributed around its circumference. A fixation to the proximal section and / or the distal section of an implantable device is carried out in such a way that the arms are threaded either through the meshes formed by the wire-shaped element 10 and / or through loops or loops. in the marginal zone of the distal end and / or proximal end. Then, after passing them, the arms are preferably placed on top of each other and fixed to the inner surface 75 of the membrane, especially by sewing, gluing, welding, crimping or other fixing. Generally, in this way, any other type of membrane can also be fixed by mechanical fixation in the marginal zone of the proximal section and / or the distal section. The membrane or the membrane-forming or membrane-shaped structure may be positioned in any area within the support structure of the implantable device 1, especially in the proximal section and / or the distal section and / or in the intermediate section zone .

Figure 12a shows the membrane 73 according to Figure 12 in a position fixed to the support structure of an implantable device 1. Here, the support structure is placed on the membrane and the protruding arms 74 are placed around the edge 21 of the support structure of the implantable device and fixed to the inner side oriented towards the distal section 30. In the present case, the arms 74 are sewn at their respective ends, through the support structure in the proximal section 20, to the surface of membrane 75 arranged on the proximal side of the support structure. In the embodiment shown according to Figure 12a, therefore, the membrane 73 is simply fixed to the proximal section. Therefore, a fixation can also be made to the distal section or both. Preferably, the membrane is fixed in such a way that it remains guaranteed that the implantable device can be deposited and retained without problems.

Another embodiment of a support structure with inserted membrane 73 is shown in Fig. 12b. The support structure has an annular shape and can be formed especially from a cut tube, but also from an element 10 in the form of a coiled wire. The arms 74 pass through eyelets 13 e, as in Figure 12a, it is fixed to the side surface 75, especially by sewing, gluing etc. The eyelets 13 can either be made in a cut tube that forms the support structure, or, during winding by the wire-shaped element. A discretionary number of these eyelets is formed within the support structure, and the ties at the edge of the support structure can obviously be used for fixing in principle to pass the arms 74 of the membrane through the membrane fixing the membrane there. .

Another variant that is not represented in the figures is the immersion of the support structure to realize a membrane-shaped structure. Here, the support structure is especially immersed in a film-forming material, after which a membrane-shaped film remains in the support structure. Depending on the material chosen from the immersion medium, certain membrane effects can be achieved in this way, especially a hydrophobic or hydrophilic surface, especially to facilitate tissue adhesion. Through this choice of material, air and / or water permeability can also be achieved. One or more monomers that form a natural or synthetic polymer, especially by polyaddition, polymerization or polycondensation, are suitable for the immersion material. Polycarbonates, polyesters, polyamides, polyolefins or polyurethane are especially suitable. Natural resins are also suitable, provided they are film-forming.

In figures 13a to 13g the launch of the implantable device 1 is shown. Here, the implantable device is disposed in the defective opening 2 in the wall 3. For this purpose, a catheter 5 with a feed tube 4 inside it is introduced in the area of the defective opening 2. In the second step (Figure 13b), the feed tube 4 is passed through the opening 2. In the third step, the implantable device 1 is ejected from the

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feed tube 4, this being fixed to a guide wire 6. First, the distal section 30 of the implantable device is deployed. In the next step (Figure 13d) the feed tube 4 is removed from the opening and the intermediate section 40 is deployed. During this, the distal section 30 is deposited on the distal outer side 7 of the wall 3. During the next withdrawal from the feed tube 4 and the catheter, the implantable device 1 on the guide wire is still ejected from the feed tube 4, initially still in elongated shape. The fastening wires 80 fixed to the proximal section, such as can best be seen in Figures 14a to 14c, are still arranged in the guidewire and inside the feed tube. In the next and penultimate placement step shown in Figure 13g, the implantable device is completely ejected from the feed tube. The holding wires are still connected with the proximal section 20. In the last step shown in Figure 13f, the guide wire and the holding wires are also removed inside the feed tube. The implantable device has completely adopted its secondary form in which the proximal section 20 is located on the proximal outer side 8 and the distal section 30 is located on the distal outer side 7 of the wall 3.

Figures 14a to 14c show the arrangement of fastening wires belonging to the location system as shown in Figures 13a to 13g. Only one holding wire may be threaded through all loops or loops at the proximal end and / or the distal end, forming a loop to pass the guide wire or without loop formation. The embodiment with a single wire threaded by all these loops is not shown in Figures 14. However, in Figure 14a the embodiment variant is shown in which two clamping wires 80, 81 pass respectively through the half of the existing loops or loops, the guidewire 6 being threaded through a loop opening 82 formed by the two clamp wires 80, 81. In this area, the two clamp wires are placed double forming a loop. The two loops overlap in a given area forming the loop opening 82 between them. Since the guide wire passes through said loop opening 82 and the two clamping wires are pulled, a fixed unit is achieved between the two wires of clamping, guide wire and implantable device.

In an alternative embodiment as shown in FIG. 14b, a chain of fastening wires is formed, the loops 83 respectively meshing each other. In the embodiment shown in Figure 14b, the guide wire is threaded only by the last loop 83 and, therefore, also holds all the others, as they are joined together. In the variant shown in Figure 14b, only four fastening wires are provided, while in the variant shown in Figure 14c, a fastening wire 80 is threaded respectively through each of the ties 22 at the proximal end of the device. . They are all chained together, passing through the last loop 83 in turn the guide wire. By pulling the fastening wires, a unit is produced between them, the guide wire 6 and the loops at the proximal end 24 of the implantable device, so that it is possible to direct the implantable device by means of the guide wire and along it. When all loops / loops are assembled at a point at the proximal end (or at the distal end) (in the area of the passage opening), in case of doubt it is enough to provide a single clamping wire and, therefore, a loop and a guide wire to establish a solid joint to direct the implantable device. On the other hand, if a remarkable passage opening is provided between the loops or loops at the proximal / distal end of the device 1, more than one clamping wire is advantageously used. For example, if 24 loops or loops are provided at the proximal end of the device, 24 clamp wires can also be provided. Generally, however, even more clamping wires can be provided if it is advantageous.

If it turns out that the implantable device has to be removed from the implantation site, because the effect to be achieved has already occurred or because the implantable device has been implanted in the wrong place, according to the invention it is also possible to remove it again and / or extract it with the location system as described above. For this purpose, a guide wire 9 and at least one extraction wire 90 are provided. The guide wire 9, however, can also be the guide wire 6 shown in the previous figures. Also, the extraction wire 90 may be identical to the holding wire 80. For the extraction of the implantable device, the extraction wire is passed to the distal side, passing through its support structure, the extraction wire being placed forming a loop. The guide wire 9 is also passed to the distal side of the implantable device 1, passing through the support structure, and is threaded through the loop 91 of the extraction wire. Then, firstly, the extraction wire 90 is pulled and then the guide wire together with the extraction wire. In this way, the extraction wire is held in the guide wire and the two together are attached to the support structure of the implantable device 1 and can be pulled into the catheter by inserting it into a catheter.

In order to allow not only the location, but also the removal of the implantable device, preferably a set of sale is offered with a location system of this type with holding wires, a guide wire, a feed tube and a catheter and, given the case, different embodiments of implantable devices.

Instead of providing the wire-shaped element, the implantable device 1 as a whole can also

55 E04703781 11-14-2011

formed from a cut tube, this is not part of the invention. This or the wire-shaped element according to Figures 1 to 14c can also be chemically and / or mechanically treated, especially by corrosion, electropolishing, microseiling or other treatment. This can also be done at least in partial areas. In this way, membrane-shaped structures can also be formed. Regardless of whether a wire-shaped element or a cut tube (by laser) is used, these are preferably composed of a biocompatible material, especially a metal or metal alloy, especially stainless steel, or a plastic such as polycarbonate , especially a shape memory material such as nitinol. The membranes, structures that form membranes or membrane-shaped structures can also be composed of a natural or synthetic material, especially of a gauze of a polymer or of cotton or of another natural material. Dracon threads and carbon fibers are also suitable. Also in this regard, preferably the material is intended to be biocompatible. The implantable device according to the invention has a special relevance in the field of VSD and AD, that is, for atrial septum defects and interventricular septum defects.

Figures 16 to 16c show different variants for joining the two wire ends 11, 12 of the wire-shaped element 10 together, in order to avoid injury to the tissue of the human or animal body, which surrounds the implantable device. As shown in Figure 16, on the one hand, it is possible to join these two ends 11, 12 by means of a bushing 100. For example, at the location 101 indicated by the two arrows, a force can be exerted to compress the bushing there. This can be done, for example, with a hammer, pressure pliers or similar auxiliary means. It is also possible to glue inside the bushing, in which case, for example, after introducing the two ends 11, 12 into the bushing, it is filled with an adhesive. It is also possible to directly or indirectly weld the ends of the bushing or any other closure thereof.

Another variant for joining the wire ends 11, 12 is shown in Figure 16a. Here, the two ends are twisted between them in such a way that a hold against accidental opening is guaranteed. Usually a twist of the wire ends between them is enough to prevent them from accidentally coming loose. However, if necessary, at least one direct or indirect welding point can be additionally placed for an even more solid connection of the two wire ends.

Laser welding or gluing of the wire ends between them is also possible, as shown in Figure 16b. Here several connection points 102 are arranged by spot welding, gluing or the like between the two wire ends.

Another alternative solution of the union of the two wire ends is shown in Figure 16c. In this case, the ends 11, 12 of the wire-shaped element are joined together through a very fine spiral 103. This can also be designated microspiral. Additionally, a glued connection is preferably provided between the spiral and the ends 11, 12 to effectively prevent the joint from being accidentally released. Obviously, other variants of the union of the ends of the wire-shaped element are also possible at discretion, especially also combinations of the embodiments represented in Figures 16 to 16c. It is also generally possible to interweave them in the support structure, as already mentioned above. Also in this case, the respective wire ends can be additionally fixed within the support structure by gluing, welding, compression etc.

The fundamental development of the development of an implantable device is represented in Figures 17a to 17e. As indicated in Figure 17a, first, a basic rolled form of the support structure is made. The preparation is preferably carried out by hand by cross-winding a wire-shaped element or cutting a tubular element correspondingly to obtain a fabric, a non-woven fabric, a net or a corresponding support structure. In a second step, the basic rolled form of the support structure is counted in an oven 110 to stabilize the basic rolled form. As material for the support structure, a shape memory material is used, especially nitinol or, for example, a plastic such as polycarbonate. After the annealing step, the conformation of the basic wound form to the desired secondary form is carried out, as indicated in Figure 17c. This presents, for example, one of the embodiments represented in the previous figures or any other that is desired in the case of application of the implantable device. As an additional processing step, the annealing of the secondary form in the oven 110, as indicated in Figure 17d, is provided. During this, the secondary form is durably printed, so that after extending the support structure or the implantable device for its introduction into a patient's body through a catheter and during the subsequent expulsion of the catheter, Automatically adopt its secondary form. After annealing and cooling, for example, the form of implantable device shown in Figure 17e is obtained. This can be applied, for example, in the field of VSD and ASD.

An alternative embodiment of a launch of the implantable device 1 is shown in Figures 18a and 18j. As described in Figures 13a to 13g, for this purpose, the implantable device is disposed in the defective opening 2 in the wall 3, pushing the catheter with the feed tube 4 through the defective opening 2

50 E04703781 11-14-2011

and the implantable device 1 is ejected from the advance tube 4. The distal section 30 is deployed. The advance tube 4 is removed from the opening 2 and the intermediate section 40 is deployed. During this, the distal section 30 is deposited on the side distal exterior 7 of the wall 3. In the next placement step shown in Figure 18c, the implantable device is completely ejected from the feed tube that has already been removed from the opening 2.

On the proximal side with respect to the wall 3, the implantable device is still ejected further from the feed tube, together with an auxiliary structure 120 and, in this embodiment, three holding wires 130, 131,

132. The fastening wires link together the proximal end 24 of the proximal section 20 and the distal end 121 of the distal section 122 of the support structure 120 (best seen in Figures 19a and 19b). Instead of three clamping wires, for example, only one or two or more than three can also be provided. The connection can be carried out, for example, in the manner shown in Figure 20. In this, the loops 22, 123 or terminal loops of the two support structures of the implantable device and of the auxiliary structure are positioned oppositely overlapping in part and the clamping wire 130 is passed alternating above and below the strands or wires of the loops. The clamping wires extend along the auxiliary structure inside the feed tube. They can also spread outside of it. In the view according to Figure 18e, the proximal section 20 and the auxiliary structure are ejected further from the feed tube and are deployed. In the view according to Figure 18f, the proximal section 20 is already almost fully deployed, as is the distal section 122 of the auxiliary structure 120. The clamping wires still extend along the auxiliary structure. During the removal of the clamping wires and the following deployment of the implantable device and of the auxiliary structure, the clamping wires extend radially outwards in the view according to Figure 18g (Figure 19a). When the holding wires are still removed, they exit the loops 22, 123 or loops of the structures and continue to project radially outward from the adjacent edges of the structures (Figure 18h). When the holding wires are further removed from the inside of the feed tube, the distal end 121 of the auxiliary structure and the proximal end 24 of the proximal section of the support structure of the implantable device are separated from each other, as indicated in Figures 18i and 19b. After further removing the holding wires and separating the structures from one another, the support structure of the implantable device is deposited and fully deployed in the opening 2. The proximal section 20 is deposited on the proximal outer side 8 of the wall 3 (figure 18j). The distal section 122 of the support structure 120 is also fully deployed. Then, the auxiliary structure can be removed again inside the feed tube and, thus, separated from the implantation site. With this procedure to deposit an implantable device, advantageously, even a possible proximal section difficult to deploy can be fully deployed. For this, it is not even necessary to match the final diameter of the deployed proximal end of the support structure of the implantable device and of the distal end 121 of the auxiliary structure. The diameter of the distal end 121 may even be larger, provided that a smooth deployment of the proximal section 20 of the implantable device is possible.

In addition to the embodiments described above and represented in the figures, others can be devised in which a single wire-shaped element is used to form the support structure. In this way, it is possible to form proximal and / or distal sections that protrude especially in the form of a plate, numerous other forms being also possible.

List of reference signs

1 implantable device

2 Defective opening

3 Wall

4 Feed tube

5 Catheter

6 Guide Wire

7 Distal outer side

8 Proximal outer side

9 Guide wire

10 Wire-shaped element

11 End 12 End 13 Eyelet 20 Proximal section 21 Marginal zone

5 22 Loop 23 Marginal area 24 Proximal end 25 Surface 26 Loop in the form of " e "

10 27 Inner space 28 Marginal zone 29 Partial zone 30 Distal section 31 Marginal zone

15 32 Loop 33 Marginal zone 34 Distal end 35 Surface 36 Marginal zone

20 37 Opening 38 Marginal zone 40 Intermediate section 41 Overlap zone 42 Connection zone

25 50 Step opening 51 Step opening 52 Opening 60 Arrow 61 Arrow

30 62 Zone 63 Longitudinal axis 70 Thread 71 Zone with thread 72 Membrane

35 73 Membrane 74 Arms 75 Inner membrane surface 80 First clamp wire 81 Second clamp wire

5 82 Loop opening 83 Loop 90 Extraction Wire 91 Tie 100 Cap

10 101 Arrows / tightening point 102 Junction points 103 Spiral 110 Furnace 120 Auxiliary structure

15 121 Distal end 122 Distal section 123 Loop 130 Clamping wire 131 Clamping wire

20 132 Clamping Wire

40 E04703781 11-14-2011

Claims (7)

1.- Implantable closure device (1) for use in the human and / or animal body for the partial closure or closure of defective openings, cavities, organic pathways etc., with a support structure that in a first state of operation (primary form) has a large relationship between length and transverse extension along an axis (63) and, in a second state of operation (secondary form), has a smaller relationship between length and extension transverse along the axis (63), the support structure presenting a proximal section (20) and a distal section (30), characterized in that, in the primary form, the support structure is formed as a tubular element with two open ends , from a single element (10) in the form of a wire by cross-winding and / or twisting and / or braiding as a fabric and / or a non-woven fabric and / or a net, the proximal end of the section being proximal (20) or the former distal stretch of the distal section (30) of the tubular support structure of the primary form pulled or folded outwardly forming loops or loops (22, 32) in the outer marginal area (21, 31), said section being proximal and / or distal section (20, 30), in the secondary form, substantially flat in the form of a disk, while the other section is initially folded out in the form of a disk and then again bent inwards, being made in the area of the passage opening in such a way that it delimits an interior space (27). 2. Implantable closure device (1) according to claim 1, characterized in that, in the secondary form, the proximal section and the distal section (20, 30) of the support structure are placed flat and partially on top of each other. , so that a closure or partial closure of openings delimited laterally by walls is possible, especially in the area of valves in the human or animal body. 3. Implantable closure device (1) according to one of the preceding claims, characterized in that at least a partial area of the implantable device (1) is configured foldable or folded. 4. Implantable closure device (1) according to one of the preceding claims, characterized in that in the secondary form of the support structure there is a central passage opening (50) in the implantable device for the partial closure of an opening (2 ). 5. Implantable closure device (1) according to one of the preceding claims, characterized in that one or more membranes (72, 73) or membrane-shaped or membrane-forming structures are incorporated in the support structure or applied thereon. . 6. Procedure for developing an implantable closure device (1) according to one of claims 1 to 5, characterized by the following steps:

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 winding of a basic wound form of the support structure from a wire-shaped element (10) by cross-winding and / or twisting and / or braiding as a fabric and / or a non-woven fabric and / or of a network,

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 annealing the basic wound form of the support structure to stabilize the shape,

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 conformation of the support structure of the basic wound form to a desired secondary form, in which the proximal end of the proximal section (20) and the distal end of the distal section (30) is pulled or folded out and in the outer marginal zone (21, 31) are formed by loops or loops (22, 32), the proximal section and / or the distal section (20, 30) being, in the secondary form, substantially flat in the form of a disk, being the other section bent inwards and configured in the area of the passage opening in such a way that it delimits an interior space (27), and

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 annealing the secondary form of the support structure to stabilize and print the shape.

7. Method according to claim 6, characterized in that the first winding step is carried out by hand.